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Terminated

The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension clinical chemistry system. For prescription use only.

FDA Recall Z-1217-2017 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJIT
Date Initiated2016-05-05
Date Terminated2018-02-02
Product Quantity24,940.00

Reason for Recall

Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.

Firm Action

Siemens mailed an Urgent Medical Device Notification letter to all affected customers on May 10, 2016. The notice provided information on actions to be taken by the customer to work around the issue. For further questions, please call (800) 441-9250.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed throughout the United States

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103836ENZYME II CALIBRATORSiemens Healthcare Diagnostics, Inc. · 2011-02-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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